Pre-emptive treatment of heart failure exacerbations in patients managed with the HeartLogic™ algorithm.

AIMS: Heart failure (HF) is a chronic disease affecting 64 million people worldwide and places a severe burden on society because of its mortality, numerous re-hospitalizations and associated costs. HeartLogic™ is an algorithm programmed into implanted devices incorporating several biometric parameters which aims to predict HF episodes. It provides an index which can be monitored remotely, allowing pre-emptive treatment of congestion to prevent acute decompensation. We aim to assess the impact and security of pre-emptive HF management, guided by the HeartLogic™ index. METHODS AND RESULTS: The HeartLogic™ France Cohort Study is an investigator-initiated, prospective, multi-centre, non-randomized study. Three hundred ten patients with a history of HF (left ventricular ejection fraction ≤40%; or at least one episode of clinical HF with elevated NT-proBNP ≥450 ng/L) and implanted with a cardioverter defibrillator enabling HeartLogic™ index calculation will be included across 10 French centres. The HeartLogic™ index will be monitored remotely for 12 months and in the event of a HeartLogic™ index ≥16, the local investigator will contact the patient for assessment and adjust HF treatment as necessary. The primary endpoint is unscheduled hospitalization for HF. Secondary endpoints are all-cause mortality, cardiovascular death, HF-related death, unscheduled hospitalizations for ventricular or atrial arrhythmia and HeartLogic™ index evolution over time. Blood samples will be collected for biobanking, and quality of life will be assessed. Finally, the safety of a HeartLogic™-triggered strategy for initiating or increasing diuretic therapy will be assessed. A blind and independent committee will adjudicate the events. CONCLUSIONS: The HeartLogic™ France Cohort Study will provide robust real-world data in a cohort of HF patients managed with the HeartLogic™ algorithm allowing pre-emptive treatment of heart failure exacerbations.

QRS-T angle: is it a specific parameter associated with sudden cardiac death in type 2 diabetes? Results from the SURDIAGENE and the Mini-Finland prospective cohorts.

AIMS/HYPOTHESIS: Type 2 diabetes is associated with a high risk of sudden cardiac death (SCD), but the risk of dying from another cause (non-SCD) is proportionally even higher. The aim of the study was to identify easily available ECG-derived features associated with SCD, while considering the competing risk of dying from non-SCD causes. METHODS: In the SURDIAGENE (Survie, Diabete de type 2 et Genetique) French prospective cohort of individuals with type 2 diabetes, 15 baseline ECG parameters were interpreted among 1362 participants (mean age 65 years; HbA1c 62±17 mmol/mol [7.8±1.5%]; 58% male). Competing risk models assessed the prognostic value of clinical and ECG parameters for SCD after adjusting for age, sex, history of myocardial infarction, N-terminal pro b-type natriuretic peptide (NT-proBNP), HbA1c and eGFR. The prospective Mini-Finland cohort study was used to externally validate our findings. RESULTS: During median follow-up of 7.4 years, 494 deaths occurred including 94 SCDs. After adjustment, frontal QRS-T angle ≥90° (sub-distribution HR [sHR] 1.68 [95% CI 1.04, 2.69], p=0.032) and NT-proBNP level (sHR 1.26 [95% CI 1.06, 1.50] per 1 log, p=0.009) were significantly associated with a higher risk of SCD. Nevertheless, frontal QRS-T angle was the only marker not to be associated with causes of death other than SCD (sHR 1.08 [95% CI 0.84, 1.39], p=0.553 ). These findings were replicated in the Mini-Finland study subset of participants with diabetes (sHR 2.22 [95% CI 1.05, 4.71], p=0.04 for SCD and no association for other causes of death). CONCLUSIONS/INTERPRETATION: QRS-T angle was specifically associated with SCD risk and not with other causes of death, opening an avenue for refining SCD risk stratification in individuals with type 2 diabetes.

Asymptomatic left circumflex artery stenosis is associated with higher arrhythmia recurrence after persistent atrial fibrillation ablation.

Background: The pathophysiology of persistent atrial fibrillation (AF) remains unclear. While several studies have demonstrated an association between myocardial infarction and atrial fibrillation, the role of stable coronary artery disease (CAD) is still unknown. As a result, we aimed to assess the association between CAD obstruction and AF recurrence after persistent AF ablation in patients with no history of CAD. Materials and methods: This observational retrospective study included consecutive patients who underwent routine preprocedural cardiac computed tomography (CCT) before persistent AF ablation between September 2015 and June 2018 in 5 European University Hospitals. Exclusion criteria were CAD or coronary revascularization previously known or during follow-up. Obstructive CAD was defined as luminal stenosis ≥ 50%. Results: All in all, 496 patients (mean age 61.8 ± 10.0 years, 76.2% males) were included. CHA2DS2-VASc score was 0 or 1 in 225 (36.3%) patients. Obstructive CAD was present in 86 (17.4%) patients. During the follow-up (24 ± 19 months), 207 (41.7%) patients had AF recurrence. The recurrence rate was not different between patients with and without obstructive CAD (43.0% vs. 41.5%, respectively; P = 0.79). When considering the location of the stenosis, the recurrence rate was higher in the case of left circumflex obstruction: 56% vs. 32% at 2 years (log-rank P ≤ 0.01). After Cox multivariate analysis, circumflex artery obstruction (HR 2.32; 95% CI 1.36-3.98; P < 0.01) was independently associated with AF recurrence. Conclusion: Circumflex artery obstruction detected with CCT was independently associated with 2-fold increase in the risk of AF recurrence after persistent AF ablation. Further research is necessary to evaluate this pathophysiological relationship.

Septal versus apical pacing sites in permanent right ventricular pacing: The multicentre prospective SEPTAL-PM study.

BACKGROUND: The optimal right ventricular pacing site for patients requiring pacemaker implantation for permanent atrioventricular block is a matter of debate. Long-term right ventricular apical pacing has been associated with left ventricular ejection fraction impairment and heart failure. Right ventricular septal pacing has been proposed as an alternative. AIM: The aim of this randomized prospective multicentre trial was to compare left ventricular remodelling and outcomes between right ventricular apical and septal pacing after mid-term follow-up. METHODS: Patients requiring pacemaker implantation for high-degree atrioventricular block were enrolled and randomized in a 1:1 fashion to receive a right ventricular apical or septal lead. RESULTS: A total of 141 patients were included, 69 in the septal group and 72 in the apical group. Both groups exhibited similar left ventricular ejection fractions after 18 months of follow-up (septal 57.1±11.9% vs. apical 57.4±13.4%), and left ventricular ejection fraction variation was similar in the two groups at the end of follow-up (septal -1.5±13.2% vs. apical 0.3±13.3%). Additionally, left ventricular volume, quality of life and 6-minute walk distance were similar in the two groups. However, patients in the septal group were more likely to be asymptomatic, with a significantly lower concentration of N-terminal prohormone of brain natriuretic peptide. Lastly, lead position did not impact 18-month survival. CONCLUSION: Pacing from the right ventricular apex does not have any detrimental effect on left ventricular systolic function compared with septal pacing over an 18-month period.

Cardiovascular outcomes after cardiac resynchronization therapy in cardiac amyloidosis.

AIMS: Cardiac resynchronization therapy (CRT) is highly effective in dilated cardiomyopathy (DCM) patients with impaired left ventricular ejection fraction (LVEF) and left bundle block branch. In cardiac amyloidosis (CA) patients, left ventricular dysfunction and conduction defects are common, but the potential of CRT to improve cardiac remodelling and survival in this particular setting remains undefined. We investigated cardiovascular outcomes in CA patients after CRT implantation in terms of CRT echocardiographic response and major cardiovascular events (MACEs). METHODS AND RESULTS: Our retrospective study included 47 CA patients implanted with CRT devices from January 2012 to February 2020, in nine French university hospitals (77 ± 6 years old, baseline LVEF 30 ± 8%) compared with propensity-matched (1:1 for age, LVEF at implantation, and CRT indication) DCM patients with a CRT device. CA patients had lower rates of CRT response (absolute delta LVEF ≥ 10%) compared with DCM patients (36% vs. 70%, P = 0.002). After multivariate Cox analysis, CA was independently associated with MACE (hospitalization for heart failure/cardiovascular death) [hazard ratio (HR) 3.73, 95% confidence interval (CI) 1.85-7.54, P < 0.001], along with the absence of CRT response (HR 3.01, 95% CI 1.56-5.79, P = 0.001). The presence of echocardiographic CRT response (absolute delta LVEF ≥ 10%) was the only predictive factor of MACE-free survival in CA patients (HR 0.36, 95% CI 0.15-0.86, P = 0.002). CONCLUSION: Compared with a matched cohort of DCM patients, CA patients had a lower rate of CRT response and consequently a worse cardiovascular prognosis after CRT implantation. However, CRT could be beneficial even in CA patients given that CRT response was associated with better cardiac outcomes in this population.

Virtual Reality for Sedation During Atrial Fibrillation Ablation in Clinical Practice: Observational Study.

BACKGROUND: Connected devices are dramatically changing many aspects in health care. One such device, the virtual reality (VR) headset, has recently been shown to improve analgesia in a small sample of patients undergoing transcatheter aortic valve implantation. OBJECTIVE: We aimed to investigate the feasibility and effectiveness of VR in patients undergoing atrial fibrillation (AF) ablation under conscious sedation. METHODS: All patients who underwent an AF ablation with VR from March to May 2020 were included. Patients were compared to a consecutive cohort of patients who underwent AF ablation in the 3 months prior to the study. Primary efficacy was assessed by using a visual analog scale, summarizing the overall pain experienced during the ablation. RESULTS: The AF cryoablation procedure with VR was performed for 48 patients (mean age 63.0, SD 10.9 years; n=16, 33.3% females). No patient refused to use the device, although 14.6% (n=7) terminated the VR session prematurely. Preparation of the VR headset took on average 78 (SD 13) seconds. Compared to the control group, the mean perceived pain, assessed with the visual analog scale, was lower in the VR group (3.5 [SD 1.5] vs 4.3 [SD 1.6]; P=.004), and comfort was higher in the VR group (7.5 [SD 1.6] vs 6.8 [SD 1.7]; P=.03). On the other hand, morphine consumption was not different between the groups. Lastly, complications, as well as procedure and fluoroscopy duration, were not different between the two groups. CONCLUSIONS: We found that VR was associated with a reduction in the perception of pain in patients undergoing AF ablation under conscious sedation. Our findings demonstrate that VR can be easily incorporated into the standard ablation workflow.

Impact of the atrial lead pacing site regarding atrial fibrillation onset in patients with sinus node dysfunction.

Symptomatic sinus node disease (SND) most frequently requires the implantation of a dual chamber pacemaker of which the right atrial lead is generally implanted in the right atrial appendage (RAA) or the lateral wall (LW).The aim of this retrospective study was to evaluate the impact of the right atrial lead pacing site regarding the onset of AF in patients with SND. RESULTS: 126 patients were included (53% males; 76 yo). 64 (51%) patients were implanted in the RAA and 62 (49%) in the LW. The two groups were not different in terms of CHA2DS2-VASc score and indexed left atrial volume. Forty-eight months after implantation, AF occurred in 17 (26.6%) of the RAA group and 6 (9.7%) in the lateral group. In the multivariate models, RAA site was the only factor associated with AF onset, with an Hazard Ratio of 2.5 (95%CI 1.1; 5.7; P=0.03). CONCLUSION: In our study, RAA pacing was associated with 2.5 higher risk of AF onset in patients with SND. Further larger randomized studies are needed to confirm these findings.

Wearable cardioverter-defibrillator in patients with a transient risk of sudden cardiac death: the WEARIT-France cohort study.

AIMS: We aimed to provide contemporary real-world data on wearable cardioverter-defibrillator (WCD) use, not only in terms of effectiveness and safety but also compliance and acceptability. METHODS AND RESULTS: Across 88 French centres, the WEARIT-France study enrolled retrospectively patients who used the WCD between May 2014 and December 2016, and prospectively all patients equipped for WCD therapy between January 2017 and March 2018. All patients received systematic education session through a standardized programme across France at the time of initiation of WCD therapy and were systematically enrolled in the LifeVest Network remote services. Overall, 1157 patients were included (mean age 60 ± 12 years, 16% women; 46% prospectively): 82.1% with ischaemic cardiomyopathy, 10.3% after implantable cardioverter-defibrillator explant, and 7.6% before heart transplantation. Median WCD usage period was 62 (37-97) days. Median daily wear time of WCD was 23.4 (22.2-23.8) h. In multivariate analysis, younger age was associated with lower compliance [adjusted odds ratio (OR) 0.97, 95% confidence interval (CI) 0.95-0.99, P < 0.01]. A total of 18 participants (1.6%) received at least one appropriate shock, giving an incidence of appropriate therapy of 7.2 per 100 patient-years. Patient-response button allowed the shock to be aborted in 35.7% of well-tolerated sustained ventricular arrhythmias and in 95.4% of inappropriate ventricular arrhythmia detection, finally resulting in an inappropriate therapy in eight patients (0.7%). CONCLUSION: Our real-life findings reinforce previous studies on the efficacy and safety of the WCD in the setting of transient high-risk group in selected patients. Moreover, they emphasize the fact that when prescribed appropriately, in concert with adequate patient education and dedicated follow-up using specific remote monitoring system, compliance with WCD is high and the device well-tolerated by the patient.

Non-invasive hemodynamic determination of patient-specific optimal pacing mode in cardiac resynchronization therapy.

PURPOSE: Cardiac resynchronization therapy (CRT) devices have multiple programmable pacing parameters. The purpose of this study was to determine the best pacing mode, i.e., associated with the greatest acute hemodynamic response, in each patient. METHODS: Patients in sinus rhythm and intact atrioventricular conduction were included within 3 months of implantation of devices featuring SyncAV and multipoint pacing (MPP) algorithms. The effect of nominal biventricular pacing using the latest activated electrode (BiV-Late), optimized atrioventricular delay (AVD), nominal and optimized SyncAV, and anatomical MPP was determined by non-invasive measurement of systolic blood pressure (SBP). CRT response was defined as SBP increase > 10% relative to baseline. RESULTS: Thirty patients with left bundle branch block (LBBB) were included. BiV-Late increased SBP compared to intrinsic rhythm (128 ± 21 mmHg vs. 121 ± 22 mmHg, p = 0.0002). The best pacing mode further increased SBP to 140 ± 19 mmHg (p < 0.0001 vs. BiV-Late). The proportion of CRT responders increased from 40% with BiV-Late to 80% with the best pacing mode (p = 0.0005). Compared to BiV-Late, optimized AVD and optimized SyncAV increased SBP (to 134 ± 21 mmHg, p = 0.004, and 133 ± 20 mmHg, p = 0.0003, respectively), but nominal SyncAV and MPP did not. The best pacing mode was variable between patients and was different from nominal BiV-Late in 28 (93%) patients. Optimized AVD was the most frequent best mode, in 14 (47%) patients. CONCLUSION: In patients with LBBB, the best pacing mode was patient-specific and doubled the magnitude of acute hemodynamic response and the proportion of acute CRT responders compared to nominal BiV-Late pacing. TRIAL REGISTRATION: ClinicalTrials.gov : NCT03779802.

Hypnosis Versus Placebo During Atrial Flutter Ablation: The PAINLESS Study: A Randomized Controlled Trial.

OBJECTIVES: The aim of this study was to assess the superiority of hypnosis versus placebo on pain perception and morphine consumption during typical atrial flutter (AFL) ablation. BACKGROUND: AFL ablation commonly requires intravenous opioid for analgesia, which can be associated with adverse outcomes. Hypnosis is an alternative technique with rising interest, but robust data in electrophysiological procedures are lacking. METHODS: This single center, randomized controlled trial compared hypnosis and placebo during AFl ablation. In addition to the randomized intervention, all patients were treated according to the institution's standard of care analgesia protocol (administration of 1 mg of intravenous morphine in case of self-reported pain ≥5 on an 11-point numeric rating scale or on demand). The primary endpoint was perceived pain quantified by patients using a visual analog scale. RESULTS: Between October 2017 and September 2019, 113 patients (mean age 70 ± 12 years, 21% women) were randomized to hypnosis (n = 56) or placebo (n = 57). Mean pain score was 4.0 ± 2.2 in the hypnosis group versus 5.5 ± 1.8 in the placebo group (p < 0.001). Pain perception, assessed every 5 min during the whole procedure, was consistently lower in the hypnosis group. Patients' sedation scores were also better in the hypnosis group than in the placebo group (8.3 ± 2.2 vs. 5.4 ± 2.5; p < 0.001). Finally, morphine requirements were significantly lower in the hypnosis group (1.3 ± 1.3 mg) compared with the placebo group (3.6 ± 1.8 mg; p < 0.001). CONCLUSIONS: In this first randomized trial, hypnosis during AFL ablation was superior to placebo for alleviating pain and reducing morphine consumption.

Prognostic value of Charlson Comorbidity Index in the elderly with a cardioverter defibrillator implantation.

BACKGROUND: Elderly patients are often underrepresented in implantable cardioverter defibrillator (ICD) trials, and ICD implantation in patients ≥75 years consequently remains controversial. We aimed to evaluate mortality, appropriate ICD therapy rates and survival gain in an elderly population after risk stratification according to the Charlson Comorbidity Index (CCI). METHODS: This monocentric retrospective study included elderly ICD patients ≥75 years. They were subdivided according to their CCI score into 3 categories (0-1, 2-3 or ≥4 points). Elderly patients were matched 1:2 with younger control ICD patients on gender, type of prevention (primary or secondary) and type of device (associated cardiac resynchronization therapy or not). RESULTS: Between January 2009 and July 2017, 121 elderly patients (mean age 78 ± 3; 83% male) matched with 242 controls (mean age 66 ± 5) were included. At 5 year follow-up after ICD implantation, overall survival was 78%, 57%, and 29% (P = 0.002) in the elderly with a CCI score of 0-1, 2-3 and ≥4 respectively, and 72% in controls. There was no significant difference regarding ICD appropriate therapy between the 3 subgroups despite a trend towards lower rates of therapy in CCI ≥ 4 points patients (34.2%, 39.7% and 22.8% respectively; P = 0.45). Median potential survival gain after an appropriate therapy was >5, 4.7 and 1.4 years, with a CCI score of 0-1, 2-3 and ≥4 respectively (P = 0.01). CONCLUSION: Elderly patients with CCI score ≥ 4 had the lowest survival after ICD implantation and little survival gain in case of appropriate defibrillator therapy. More than age alone, the burden of comorbidities assessed by the CCI could be helpful to better select elderly patients for ICD implantation.

High Risk of Sustained Ventricular Arrhythmia Recurrence After Acute Myocarditis.

Acute myocarditis is associated with cardiac arrhythmia in 25% of cases; a third of these arrhythmias are ventricular tachycardia (VT) or ventricular fibrillation (VF). The implantation of a cardiac defibrillator (ICD) following sustained ventricular arrhythmia remains controversial in these patients. We sought to assess the risk of major arrhythmic ventricular events (MAEs) over time in patients implanted with an ICD following sustained VT/VF in the acute phase of myocarditis compared to those implanted for VT/VF occurring on myocarditis sequelae. Our retrospective observational study included patients implanted with an ICD following VT/VF during acute myocarditis or VT/VF on myocarditis sequelae, from 2007 to 2017, in 15 French university hospitals. Over a median follow-up period of 3 years, MAE occurred in 11 (39%) patients of the acute myocarditis group and 24 (60%) patients of the myocarditis sequelae group. Kaplan-Meier MAE rate estimates at one and three years of follow-up were 19% and 45% in the acute group, and 43% and 64% in the sequelae group. Patients who experienced sustained ventricular arrhythmias during acute myocarditis had a very high risk of VT/VF recurrence during follow-up. These results show that the risk of MAE recurrence remains high after resolution of the acute episode.

[Screening and diagnosis of atrial fibrillation]. / Dépistage et diagnostic de la fibrillation atriale.

Screening and diagnosis of atrial fibrillation. Screening for atrial fibrillation (AF) is crucial as this arrhythmia is asymptomatic in a third of patients and 5% of patients present a stroke as the first manifestation of their AF. The European Society of Cardiology recommends opportunistic screening of AF in patients over 65 years of age and systematically in patients over 75 years of age. The simplest way is pulse taking, but the number of connected devices for AF screening allows to multiply the frequency of screening and thus increase sensitivity, with another advantage of a digitalized transmission of the tracing. However many questions remain. No scientific evidence has demonstrated a benefit for AF screening. We do not know what duration and frequency of screening is relevant. The burden of AF which increases thromboembolic risk is not known. What population should be screened and how to consider subclinical AF? We will obtain answers to our questions in the coming years thanks to the results of the various studies in progress.

Dépistage et diagnostic de la fibrillation atriale. Le dépistage de la fibrillation atriale (FA) est primordial, car cette arythmie est asymptomatique chez 15 à 30 % des patients, et 1 patient sur 20 est victime d'un accident vasculaire cérébral comme première manifestation de sa fibrillation. La Société européenne de cardiologie recommande le dépistage de la FA de manière opportuniste chez les plus de 65 ans et de manière systématique chez les plus de 75 ans. Le moyen le plus simple est la prise du pouls, mais les objets connectés permettent dorénavant de multiplier la fréquence de dépistage, et donc d'augmenter la sensibilité, avec aussi l'avantage d'une transmission numérisée du tracé pour la plupart. Enfin, ils sont moins contraignants que les appareils les plus anciens. Toutefois, de nombreuses questions demeurent. Il n'y a pas encore de preuve scientifique ayant démontré un bénéfice du dépistage de la FA. Nous ne savons pas quelle durée et quelle fréquence de dépistage sont pertinentes. La durée de fibrillation à partir de laquelle il existe une augmentation du risque thromboembolique n'est pas connue. Quelle population faut-il dépister et comment faut-il considérer la fibrillation infraclinique ? Nous obtiendrons des réponses à nos interrogations dans les prochaines années grâce aux résultats des différentes études en cours.

Baroreflex sensitivity assessed with the sequence method is associated with ventricular arrhythmias in patients implanted with a defibrillator for the primary prevention of sudden cardiac death.

BACKGROUND: Left ventricular ejection fraction lacks accuracy in predicting sudden cardiac death, resulting in unnecessary implantation of cardioverter defibrillators for the primary prevention of sudden cardiac death. Baroreflex sensitivity could help to stratify patients at risk of ventricular arrhythmia. AIM: To assess the association between cardiac baroreflex sensitivity and ventricular arrhythmias in patients implanted with an implantable cardioverter defibrillator for the primary prevention of sudden cardiac death after myocardial infarction. METHODS: This case-control single-centre study took place between 2015 and 2016. Cases (n=10) had experienced ventricular arrhythmias treated by the implantable cardioverter defibrillator in the previous 3 years; controls (n=22) had no arrhythmia during the same period. Baroreflex sensitivity was assessed using the temporal sequence method (mean slope) and cross-spectral analysis (low-frequency gain and high-frequency gain). RESULTS: The mean age was 65 years; 94% of the patients were men. 24-hour Holter electrocardiogram autonomous nervous system variables, left ventricular ejection fraction and N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) concentration did not differ between cases and controls. The mean slope was lower in cases than in controls (8 vs. 15ms/mmHg [P=0.009] in the supine position; 7 vs. 12ms/mmHg [P=0.038] in the standing position). The mean slope in the supine position was still significantly different between groups after adjustment for age, left ventricular ejection fraction and NT-proBNP (P=0.03). By comparison, low-frequency gain and high-frequency gain did not differ between groups in either the supine or the standing position. CONCLUSION: Patients with ventricular arrhythmias had a lower mean slope compared with those who were free of arrhythmia. A prospective study is needed to confirm this association.

Twenty-four-hour ambulatory ECG monitoring relevancy in myotonic dystrophy type 1 follow-up: Prognostic value and heart rate variability evolution.

BACKGROUND: Patient prognosis in type 1 myotonic dystrophy (DM1) is very poor. Annual 24-hour holter ECG monitoring is recommended but its relevance is debated. Main objective was to determine whether holter ECG parameters could predict global death in DM1 patients and secondarily to assess whether they could predict cardiovascular events and sudden cardiac death, to compare DM1 patients and healthy controls, and to assess their evolution in DM1 over a 5-year period. METHODS: This retrospective study included genetically confirmed DM1. Primary endpoint was global death. Secondary endpoints were labeled "sudden cardiac death" which was a composite of sudden cardiac death, aborted sudden cardiac death, implantable cardioverter defibrillator therapy, sustained ventricular tachycardia, atrioventricular block grade 3, pause >3 s; and "cardiovascular events" which was a composite of all-cause mortality, pacemaker or cardioverter defibrillator implantation, sustained ventricular tachycardia, supraventricular tachycardia, hospitalization for acute cardiac cause and heart failure. RESULTS: Forty-seven patients (22 women, 40 ± 13 years old) were included. Three (7%) DM1 patients died, 9 (19%) experienced "sudden cardiac death" endpoint and 21 (45%) experienced "cardiovascular event" endpoint during mean follow-up of 95 ± 22 months. None of holter ECG parameters were discriminant to predict death or secondary endpoints. Compared to healthy controls, DM1 patients had higher SDNN and LF/HF ratio. Finally, heart rate variability parameters remained stable over a mean interval of 61 ± 15 months excepting pNN50 which decreased significantly. CONCLUSION: Results suggest that annually-repeated holter ECG in DM1 is not useful for stratifying risk of sudden death and cardiovascular outcomes.

Contractibility sensor signal evolution predicts cardiovascular events in patients with cardiac resynchronization therapy.

BACKGROUND: While a multicentre trial has demonstrated that the SonR™ contractibility sensor is as effective as echocardiography-guided optimization at improving response to cardiac resynchronization therapy, an association between SonR™ values and clinical endpoints has not been established. AIMS: The primary objective was to assess the predictive value of SonR™ signal evolution regarding cardiovascular events in patients implanted with a cardiac resynchronization therapy device. The secondary objective was to evaluate whether SonR™ signal evolution was associated with cardiovascular death. METHODS: All patients with a SonR™ system implanted between 2012 and 2016 were included in this retrospective study. SonR™ signal evolution was calculated over the first 6 months after implantation: ([month 6 value-month 1 value]/month 1 value)*100. The primary endpoint (cardiovascular events) was a composite of cardiovascular death, hospitalization for acute heart failure or ventricular arrhythmia. RESULTS: Seventy-four patients (median age 67 years; 81% men) were followed up over a median 20 (13; 29) months. Cumulative incidence function showed that SonR™ signal evolution was predictive of cardiovascular events (threshold<10.70%; P=0.023) and predictive of cardiovascular death (P=0.0018). After multivariable analysis, SonR™ signal evolution was independently associated with the onset of cardiovascular events (hazard ratio: 4.03, 95% confidence interval: 1.31-12.43; P=0.015), even after adjustment for left bundle branch block and chronic kidney disease. CONCLUSIONS: In this first study publishing data on SonR™ signals in a real-life setting, SonR™ signal evolution over the first 6 months after cardiac resynchronization implantation was an independent predictor of cardiovascular events at follow-up. This variable could be useful to identify patients at higher risk of further adverse events after cardiac resynchronization implantation.

Occurrence of significant long PR intervals in patients implanted for sinus node dysfunction and monitored with SafeR™: The PRECISE study.

BACKGROUND: Long PR intervals may increase cardiovascular complications, including atrial fibrillation. In pacemakers, the SafeR™ mode monitors PR intervals, switching from AAI to DDD when criteria for atrioventricular block are met. AIMS: The PRECISE study evaluated the incidence and predictors of long PR intervals and their association with incident atrial fibrillation after 1 year in patients implanted for sinus node dysfunction and free from significant conduction disorders at baseline. METHODS: This French, prospective, multicentre, observational trial enrolled patients implanted with a REPLY™ dual-chamber pacemaker. Pacemaker memory recorded long PR intervals (defined as first-degree atrioventricular block mode switches occurring after six consecutive PR/AR intervals≥350/450ms) and atrial fibrillation incidence (fallback mode switch>1minute/day). Predictors were identified from baseline variables (age, sex, AR and PR intervals, atrial rhythm disorder and medication) using logistic regression. RESULTS: Of 291 patients with sinus node dysfunction enrolled, 214 were free from significant conduction disorders at baseline (mean age 79±8 years; 44% men; PR/AR intervals<350/450ms). After 1 year, long PR intervals had occurred in 116 patients (54%) and atrial fibrillation in 63 patients (30%). Amiodarone was the only independent predictor of long PR interval occurrence (odds ratio 2.50, 95% confidence interval 1.20-5.21; P=0.014). There was a strong trend towards an association between long PR interval and atrial fibrillation incidence (odds ratio 1.86, 95% confidence interval 0.97-3.61; P=0.051). CONCLUSIONS: Half of the patients with pure sinus node dysfunction developed long PR intervals in the year following pacemaker implantation. Amiodarone was the only independent predictor of long PR intervals. There was a strong trend towards an association between long PR intervals and incident atrial fibrillation.

Subcutaneous cardioverter defibrillator has longer time to therapy but is less cardiotoxic than transvenous cardioverter defibrillator. Study carried out in a preclinical porcine model.

Aims: Totally subcutaneous implantable cardioverter defibrillator (S-ICD) delivers higher shock energy and can have longer time to therapy compared to transvenous implantable cardioverter defibrillator (T-ICD). Aim of the study was to compare time to therapy and to investigate cardiac, cerebral and systemic injuries of S-ICD and T-ICD shocks delivered after ventricular fibrillation (VF) induction. Methods and results: Fourteen pigs were randomly implanted with a S-ICD (n = 7) or a T-ICD (n = 7). Five VF episodes were induced in each pig. For each VF episode, up to two shocks could be delivered by the T-ICD or the S-ICD to terminate the arrhythmia. Cardiac, systemic, and cerebral toxicity were monitored. Mean time to therapy was longer in the S-ICD group compared to the T-ICD group (19[18; 23] s vs. 9 [7; 10] s; P = 0.001, respectively). High-sensitivity troponin T levels were significantly higher in the T-ICD group from 1 to 24 h after the procedure (P ≤ 0.02). Creatine phosphokinase activity levels were significantly higher in the S-ICD group, at 3, 6, and 24 h after the procedure (P ≤ 0.05). Lactate levels were not significantly different between groups. S100 protein level was similar in both groups at 1 h after the procedure and then decreased in the T-ICD group compared to the S-ICD group (P = 0.04). Conclusions: Time to therapy in S-ICD was twice as long as for T-ICD, but didn't induce relevant brain injury. Conversely, S-ICD shocks were less cardiotoxic than T-ICD shocks.

Right ventricular longitudinal strain: a tool for diagnosis and prognosis in light-chain amyloidosis.

OBJECTIVES: Light-chain (AL) amyloidosis can lead to an infiltrative cardiomyopathy with increased wall thickness (IWT) of very poor prognosis. Our primary aim was to analyse the right ventricle (RV) in patients with IWT to discriminate AL amyloidosis from IWT due to hypertrophic cardiomyopathy (HCM) or to arterial hypertension (HTN). Our secondary aim was to assess if RV dysfunction predicts overall mortality in cardiac AL amyloidosis. METHODS: We retrospectively and consecutively compared clinical, biological and echocardiographic data of 315 patients with IWT: 105 biopsy-proven AL amyloidosis patients, 105 patients with HCM and 105 patients with HTN. The prognostic value of these parameters was analysed in the AL amyloidosis group. RESULTS: Free-wall right ventricular longitudinal strain (FWRVLS) worse than -21.2% discriminates AL amyloidosis [area under the curve (AUC) = 0.744)] from patients with IWT due to other aetiologies. In AL amyloidosis, FWRVLS is the strongest echocardiographic prognostic marker with AUC =0.722 and -16.5% as the optimal cut-off value, beyond which overall mortality increases significantly. It is also the only independent echocardiographic predictor of overall mortality (HR =1.113; 95%CI 1.029-1.204; p = .007), even when adjusted to the Mayo stage and global left ventricular longitudinal strain. CONCLUSIONS: FWRVLS should be considered in the diagnostic and prognostic workup in light-chain amyloidosis.